RU2019107976A - VACCINE COMPOSITION - Google Patents

VACCINE COMPOSITION Download PDF

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RU2019107976A
RU2019107976A RU2019107976A RU2019107976A RU2019107976A RU 2019107976 A RU2019107976 A RU 2019107976A RU 2019107976 A RU2019107976 A RU 2019107976A RU 2019107976 A RU2019107976 A RU 2019107976A RU 2019107976 A RU2019107976 A RU 2019107976A
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seq
virus
amino acid
acid sequence
tumor
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RU2019107976A
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Дэвид Ф. СТОЙДЛ
Джон Кэмерон БЕЛЛ
Брайан ЛИХТИ
Джонатан ПОЛ
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Тёрнстоун Лимитед Партнершип
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Claims (50)

1. Гетерологичная прайм-буст вакцина для применения в лечении рака у млекопитающего, содержащая1. A heterologous prime boost vaccine for use in the treatment of cancer in a mammal, comprising первый вирус, содержащий нуклеиновую кислоту, способную экспрессировать опухолеассоциированный антиген ВПЧ, причем указанный первый вирус способен вызывать иммунитет к указанному опухолеассоциированному антигену ВПЧ; a first virus comprising a nucleic acid capable of expressing a tumor associated HPV antigen, said first virus being capable of inducing immunity to said tumor associated HPV antigen; второй вирус, причем указанный второй вирус представляет собой везикуловирус, при этом второй вирус содержит нуклеиновую кислоту, способную экспрессировать опухолеассоциированный антиген ВПЧ, причем указанный второй вирус способен обеспечивать терапевтический онколитический эффект у указанного млекопитающего;a second virus, said second virus being a vesiculovirus, wherein the second virus contains a nucleic acid capable of expressing a tumor-associated HPV antigen, said second virus being capable of providing a therapeutic oncolytic effect in said mammal; причем указанный первый вирус иммунологически отличается и физически изолирован от указанного второго вируса; иwherein said first virus is immunologically different and physically isolated from said second virus; and при этом либо (i) указанный опухолеассоциированный антиген ВПЧ содержит аминокислотную последовательность, которая по меньшей мере на 80% идентична SEQ ID NO. 7; или (ii) второй вирус представляет собой вирус Maraba MG1.wherein either (i) said tumor associated HPV antigen contains an amino acid sequence that is at least 80% identical to SEQ ID NO. 7; or (ii) the second virus is Maraba MG1 virus. 2. Гетерологичная прайм-буст вакцина по п. 1, характеризующаяся тем, что второй вирус представляет собой Maraba MG1.2. A heterologous prime boost vaccine according to claim 1, characterized in that the second virus is Maraba MG1. 3. Гетерологичная прайм-буст вакцина по п. 1 или 2, характеризующаяся тем, что указанный опухолеассоциированный антиген ВПЧ, экспрессируемый указанной нуклеиновой кислотой в указанном первом, указанном втором вирусе, или в обоих вирусах, содержит аминокислотную последовательность, которая по меньшей мере на 80% идентична SEQ ID NO: 7.3. The heterologous prime boost vaccine according to claim 1 or 2, characterized in that said tumor-associated HPV antigen expressed by said nucleic acid in said first, said second virus, or both, contains an amino acid sequence that is at least 80 % identical to SEQ ID NO: 7. 4. Гетерологичная прайм-буст вакцина по п. 3, характеризующаяся тем, что указанная аминокислотная последовательность по меньшей мере на 90% идентична SEQ ID NO: 7.4. The heterologous prime boost vaccine of claim 3, wherein said amino acid sequence is at least 90% identical to SEQ ID NO: 7. 5. Гетерологичная прайм-буст вакцина по п. 3, характеризующаяся тем, что указанная аминокислотная последовательность по меньшей мере на 95% идентична SEQ ID NO: 7.5. The heterologous prime boost vaccine of claim 3, wherein said amino acid sequence is at least 95% identical to SEQ ID NO: 7. 6. Гетерологичная прайм-буст вакцина по п. 5, характеризующаяся тем, что указанная аминокислотная последовательность содержит SEQ ID NO: 7.6. The heterologous prime boost vaccine of claim 5, wherein said amino acid sequence comprises SEQ ID NO: 7. 7. Гетерологичная прайм-буст вакцина по п. 6, характеризующаяся тем, что указанная аминокислотная последовательность состоит из SEQ ID NO: 7.7. The heterologous prime boost vaccine of claim 6, wherein said amino acid sequence consists of SEQ ID NO: 7. 8. Гетерологичная прайм-буст вакцина по п. 6, характеризующаяся тем, что указанная аминокислотная последовательность кодируется нуклеотидной последовательностью SEQ ID NO: 8.8. The heterologous prime boost vaccine of claim 6, wherein said amino acid sequence is encoded by the nucleotide sequence of SEQ ID NO: 8. 9. Гетерологичная прайм-буст вакцина по п. 8, характеризующаяся тем, что вирус Maraba MG1 содержит обратно-комплементарную и РНК-версию нуклеотидной последовательности SEQ ID NO: 9.9. The heterologous prime boost vaccine according to claim 8, characterized in that the Maraba MG1 virus contains the back-complementary and RNA version of the nucleotide sequence of SEQ ID NO: 9. 10. Гетерологичная прайм-буст вакцина по любому из пп. 1-9, характеризующаяся тем, что указанный первый вирус включен в состав для внутримышечного введения, и указанный второй вирус включен в состав для внутривенного введения.10. Heterologous prime boost vaccine according to any one of paragraphs. 1-9, characterized in that the said first virus is included in the composition for intramuscular administration, and the specified second virus is included in the composition for intravenous administration. 11. Гетерологичная прайм-буст вакцина по любому из пп. 1-10, характеризующаяся тем, что указанные первый и второй вирусы экспрессируют один и тот же опухолеассоциированный антиген ВПЧ.11. The heterologous prime boost vaccine according to any one of claims. 1-10, characterized in that the said first and second viruses express the same tumor-associated HPV antigen. 12. Гетерологичная прайм-буст вакцина по любому из пп. 1-11, характеризующаяся тем, что рак представляет собой рак шейки матки.12. Heterologous prime boost vaccine according to any one of paragraphs. 1-11, characterized in that the cancer is cervical cancer. 13. Антигенный белок ВПЧ, содержащий аминокислотную последовательность, которая по меньшей мере на 80% идентична SEQ ID NO: 7.13. Antigenic HPV protein containing an amino acid sequence that is at least 80% identical to SEQ ID NO: 7. 14. Антигенный белок ВПЧ по п. 13, причем указанный антигенный белок содержит аминокислотную последовательность, которая по меньшей мере на 90% идентична SEQ ID NO: 7.14. The HPV antigenic protein of claim 13, wherein said antigenic protein contains an amino acid sequence that is at least 90% identical to SEQ ID NO: 7. 15. Антигенный белок ВПЧ по п. 13, причем указанный антигенный белок содержит аминокислотную последовательность, которая по меньшей мере на 95% идентична SEQ ID NO: 7.15. The HPV antigenic protein of claim 13, wherein said antigenic protein contains an amino acid sequence that is at least 95% identical to SEQ ID NO: 7. 16. Антигенный белок ВПЧ по п. 13, причем указанный антигенный белок содержит аминокислотную последовательность SEQ ID NO: 7.16. The HPV antigenic protein of claim 13, wherein said antigenic protein contains the amino acid sequence of SEQ ID NO: 7. 17. Антигенный белок ВПЧ по п. 13, причем указанный антигенный белок состоит из аминокислотной последовательности SEQ ID NO: 7.17. The HPV antigenic protein of claim 13, wherein said antigenic protein consists of the amino acid sequence of SEQ ID NO: 7. 18. Антигенный белок ВПЧ по п. 16, причем указанный антигенный белок кодируется нуклеотидной последовательностью SEQ ID NO: 8.18. The HPV antigenic protein of claim 16, wherein said antigenic protein is encoded by the nucleotide sequence of SEQ ID NO: 8. 19. Выделенная вирусная частица, содержащая последовательность нуклеиновой кислоты, способную кодировать антигенный белок по п. 13.19. An isolated viral particle containing a nucleic acid sequence capable of encoding an antigenic protein according to claim 13. 20. Выделенная вирусная частица по п. 19, причем указанная вирусная частица представляет собой везикуловирус.20. The selected viral particle according to claim 19, wherein said viral particle is a vesiculovirus. 21. Выделенная вирусная частица по п. 20, причем указанный выделенный везикуловирус представляет собой частицу Maraba MG1.21. The isolated viral particle according to claim 20, wherein said isolated vesiculovirus is a Maraba MG1 particle. 22. Выделенная вирусная частица по любому из пп. 19-21, причем указанная нуклеотидная последовательность кодирует белок, содержащий аминокислотную последовательность, которая по меньшей мере на 90% идентична SEQ ID NO:7.22. The isolated viral particle according to any one of paragraphs. 19-21, and the specified nucleotide sequence encodes a protein containing an amino acid sequence that is at least 90% identical to SEQ ID NO: 7. 23. Выделенная вирусная частица по любому из пп. 19-21, причем указанная нуклеотидная последовательность кодирует белок, содержащий аминокислотную последовательность, которая по меньшей мере на 95% идентична SEQ ID NO:7.23. The isolated viral particle according to any one of paragraphs. 19-21, and the specified nucleotide sequence encodes a protein containing an amino acid sequence that is at least 95% identical to SEQ ID NO: 7. 24. Выделенная вирусная частица по любому из пп. 19-21, причем указанная нуклеотидная последовательность кодирует белок, содержащий аминокислотную последовательность SEQ ID NO: 7.24. The isolated viral particle according to any one of paragraphs. 19-21, and the specified nucleotide sequence encodes a protein containing the amino acid sequence of SEQ ID NO: 7. 25. Выделенная вирусная частица по любому из пп. 19-21, причем указанная нуклеотидная последовательность кодирует белок, состоящий из аминокислотной последовательности SEQ ID NO: 7.25. The isolated viral particle according to any one of paragraphs. 19-21, and the specified nucleotide sequence encodes a protein consisting of the amino acid sequence of SEQ ID NO: 7. 26. Выделенная вирусная частица по п. 24, причем указанная аминокислотная последовательность кодируется нуклеотидной последовательностью SEQ ID NO: 8.26. The selected viral particle according to claim 24, wherein said amino acid sequence is encoded by the nucleotide sequence of SEQ ID NO: 8. 27. Выделенная вирусная частица по п. 24, причем вирусная частица Maraba MG1 содержит обратно-комплементарную и РНК-версию нуклеотидной последовательности SEQ ID NO: 9.27. The isolated viral particle according to claim 24, wherein the Maraba MG1 virus particle contains the inverse complementary and RNA version of the nucleotide sequence of SEQ ID NO: 9. 28. Выделенная вирусная частица по п. 27, причем обратно-комплементарная и РНК-версия нуклеотидной последовательности SEQ ID NO: 9 способна экспрессировать антиген ВПЧ последовательности SEQ ID NO: 7.28. The isolated viral particle according to claim 27, wherein the back-complementary and RNA version of the nucleotide sequence of SEQ ID NO: 9 is capable of expressing an antigen of the HPV sequence of SEQ ID NO: 7. 29. Способ лечения млекопитающего с раком, где указанный рак экспрессирует антигенный белок ВПЧ, причем указанный способ включает:29. A method of treating a mammal with cancer, wherein said cancer expresses an HPV antigenic protein, said method comprising: a) введение первого вируса, содержащего нуклеиновую кислоту, способную экспрессировать опухолеассоциированный антиген ВПЧ, причем указанный первый вирус способен вызывать иммунитет к указанному опухолеассоциированному антигену ВПЧ; a) introducing a first virus containing a nucleic acid capable of expressing a tumor-associated HPV antigen, said first virus being capable of inducing immunity to said tumor-associated HPV antigen; b) введение второго вируса, причем указанный второй вирус представляет собой везикуловирус, при этом второй вирус содержит нуклеиновую кислоту, способную экспрессировать опухолеассоциированный антиген ВПЧ, причем указанный второй вирус способен обеспечивать терапевтический онколитический эффект у указанного млекопитающего;b) introducing a second virus, said second virus being a vesiculovirus, wherein the second virus comprises a nucleic acid capable of expressing a tumor-associated HPV antigen, said second virus being capable of providing a therapeutic oncolytic effect in said mammal; причем указанный первый вирус иммунологически отличается и физически изолирован от указанного второго вируса; иwherein said first virus is immunologically different and physically isolated from said second virus; and при этом либо (i) указанный опухолеассоциированный антиген ВПЧ содержит аминокислотную последовательность, которая по меньшей мере на 80% идентична SEQ ID NO. 7; или (ii) второй вирус представляет собой вирус Maraba MG1.wherein either (i) said tumor associated HPV antigen contains an amino acid sequence that is at least 80% identical to SEQ ID NO. 7; or (ii) the second virus is Maraba MG1 virus. 30. Способ по п. 29, в котором указанный второй вирус представляет собой Maraba MG1.30. The method of claim 29, wherein said second virus is Maraba MG1. 31. Способ по п. 29 или 30, в котором указанный опухолеассоциированный антиген ВПЧ, экспрессируемый указанной нуклеиновой кислотой в указанном первом, указанном втором вирусе, или в обоих вирусах, содержит аминокислотную последовательность, которая по меньшей мере на 80% идентична SEQ ID NO: 7.31. The method of claim 29 or 30, wherein said tumor associated HPV antigen expressed by said nucleic acid in said first, said second virus, or both, comprises an amino acid sequence that is at least 80% identical to SEQ ID NO: 7. 32. Способ по п. 31, в котором указанная аминокислотная последовательность по меньшей мере на 90% идентична SEQ ID NO: 7.32. The method of claim 31, wherein said amino acid sequence is at least 90% identical to SEQ ID NO: 7. 33. Способ по п. 32, в котором указанная аминокислотная последовательность по меньшей мере на 95% идентична SEQ ID NO: 7.33. The method of claim 32, wherein said amino acid sequence is at least 95% identical to SEQ ID NO: 7. 34. Способ по п. 33, в котором указанная аминокислотная последовательность содержит SEQ ID NO: 7.34. The method of claim 33, wherein said amino acid sequence comprises SEQ ID NO: 7. 35. Способ по п. 33, в котором указанная аминокислотная последовательность состоит из SEQ ID NO: 7.35. The method of claim 33, wherein said amino acid sequence consists of SEQ ID NO: 7. 36. Способ по п. 34, в котором указанная аминокислотная последовательность кодируется нуклеотидной последовательностью SEQ ID NO: 8.36. The method of claim 34, wherein said amino acid sequence is encoded by the nucleotide sequence of SEQ ID NO: 8. 37. Способ по п. 34, в котором геном Maraba MG1 содержит обратно-комплементарную и РНК-версию нуклеотидной последовательности SEQ ID NO: 9.37. The method of claim 34, wherein the Maraba MG1 genome contains the inverse complementary and RNA version of the nucleotide sequence of SEQ ID NO: 9. 38. Способ по любому из пп. 29-37, в котором указанный первый вирус вводят внутримышечно, и второй вирус вводят внутривенно.38. The method according to any one of paragraphs. 29-37, wherein said first virus is administered intramuscularly and the second virus is administered intravenously. 39. Способ по любому из пп. 29-38, в котором указанные первый и второй вирусы оба экспрессируют один и тот же опухолеассоциированный антиген ВПЧ.39. The method according to any one of paragraphs. 29-38, wherein said first and second viruses both express the same tumor-associated HPV antigen. 40. Способ по п. 39, в котором указанный опухолеассоциированный антиген ВПЧ содержит аминокислотную последовательность SEQ ID NO: 7.40. The method of claim 39, wherein said tumor-associated HPV antigen comprises the amino acid sequence of SEQ ID NO: 7. 41. Способ по любому из пп. 29-40, в котором рак экспрессирует белки E6 или E7 ВПЧ в качестве антигенных белков.41. The method according to any one of paragraphs. 29-40, in which the cancer expresses HPV E6 or E7 proteins as antigenic proteins. 42. Способ по любому из пп. 29-41, в котором рак представляет собой рак шейки матки. 42. The method according to any one of paragraphs. 29-41, in which the cancer is cervical cancer.
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